Systems and methods relating to associating a medical implant with a delivery device

ABSTRACT

The present invention provides devices and methods for associating an implantable sling with a delivery device for delivering the sling to an anatomical location in a patient.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.10/991,906 filed on Nov. 17, 2004, which claims the benefit of U.S.Provisional Application No. 60/523,208 filed Nov. 17, 2003, the entirecontents of which are incorporated herein by reference.

FIELD OF THE INVENTION

The invention relates generally to structures located on medicalimplants and/or on implant delivery devices for associating the medicalimplant with the delivery device.

BACKGROUND OF THE INVENTION

Urinary incontinence occurs in both men and women. Various types ofincontinence are caused by different conditions and call for differenttreatments. For example, stress urinary incontinence (SUI) is known tobe caused by at least two conditions, intrinsic sphincter deficiency(ISD) and hypermobility. These conditions may occur independently or incombination. In ISD, the urinary sphincter valve, located within theurethra, fails to close properly (coapt), causing urine to leak out ofthe urethra during stressful activity. Hypermobility is a condition inwhich the pelvis floor is distended, weakened or damaged, causing thebladder neck and proximal urethra to rotate and descend in response toincreases in intra-abdominal pressure (for example, due to sneezing,coughing, straining, etc.). As a result, the patient's response timebecomes insufficient to promote urethral closure and, consequently, thepatient suffers from urine leakage and/or flow.

A popular treatment of SUI uses a surgical sling placed under thebladder neck or the mid-urethra to provide a urethral platform.Placement of the sling limits the endopelvis fascia drop. Onedisadvantage of conventional medical implant systems is that theytypically require attaching the implant to a delivery device of somesort. In some instances the making and/or breaking the interconnectionrequires significant mechanical force, which can be both inconvenientfor a medical operator and can risk damage to patient tissue near theimplantation site.

Accordingly, there is a need for an improved approach to associating amedical implant, such as a sling assembly, with a delivery device.

SUMMARY OF THE INVENTION

The invention relates to cooperating structures for associating amedical implant with a delivery device or assembly (collectively a“delivery device”). According to a preferred embodiment, the medicalimplant includes an implantable sling and the delivery device is adevice for delivering the implantable sling to an anatomical location inthe body of a patient. Preferably, the sling is configured formidurethral placement for treating urinary incontinence. In someembodiments, the sling resides, at least partially, in a protectivesheath, and is part of a sling assembly. According to variousembodiments, a structure located on an end of the sling assemblycooperates with a mating structure on a distal portion of a deliverydevice shaft to associate the sling assembly with the delivery device.According to one aspect, the structure located on the sling assemblyincludes an association loop.

According to one embodiment, the association loop attaches to a dilator,also located at the end of the sling assembly. In one preferredconfiguration, the sling assembly includes a dilator at each end, withan association loop extending out of an end of each dilator. Theassociation loops may be oriented, for example, in substantially thesame plane as a sling included in the sling assembly, or in a planesubstantially orthogonal to the plane of the sling. The association loopmay be formed from a substantially rigid material or may be formed froma deformable material. Preferably, the association loop is formed from adeformable, yet generally resilient, shape-retaining material. However,in some configurations, the association loop is formed from anon-shape-retaining, suture-like material. According to a furtherembodiment, a filament is embedded and secured along the length of adilator, and extends from a conical tip of the dilator to form anassociation loop. In one configuration, the dilator has an axiallyextending channel, and the filament ends are affixed in the axiallyextending channel by crimping them within a crimp tube. In otherconfigurations, the dilator includes a biasing member, such as a spring,interfitted with the crimp tube within a cavity of the dilator.According to one feature, pulling on the association loop compresses thespring and extends more of the loop filament out of the dilator toeffectively increase the size of the association loop. When the pullingceases, the spring decompresses to retract a portion of the loopfilament into the dilator and effectively reducing the size of theassociation loop. The bias spring may also be configured to enable theassociation loop to rotate relative to the dilator to allow the medicaloperator to twist or untwist the sling while the loop is coupled to thedelivery device. The loop may include features, such as one or morebends, to maintain the loop external to the dilator.

In an alternative embodiment, a portion of the association loop externalbut near to the dilator may be twisted to effectively reduce the size ofthe association loop. The twisted section may also be employed toposition an open portion of the association loop a desired referencedistance from the dilator. In another embodiment, the association loopis placed a desired reference distance from the dilator by placing atube of a desired length between the dilator and the loop. The tube maybe separate from or part of the dilator.

The association loop may be formed from a single or multi-strandedfilament. Multiple strands of material may be twisted together to form aflexible and/or resilient loop filament. In another embodiment, themultiple strands may be woven together to form a braided filament.Alternatively, the multiple strands may be woven to form a tube-shapedfilament having an inner and outer diameter. An association loop formedfrom a braided tube may change shape when a force is applied. Forexample, in response to pulling on the association loop, its length mayincrease while the inner and outer diameters of the filament decrease.In other embodiments, the loop may be coated with a polymer.

In one aspect of the invention, the structure located in the distalportion of the delivery device shaft includes an L- or T-shaped slot. Inone configuration, an a L-slot is formed as a first section extendingradially into the distal portion of the delivery device shaft, and asecond section extending from an inner end of the first section axiallyin a distal direction along the delivery device shaft. In alternativeembodiments, the second section of the L-slot extends axially in aproximal direction. The slot may include additional structures, such asindentations, protuberances, coatings, and/or flaps for impeding, butnot prohibiting, the association loop from disassociating with theL-slot. Additionally, the radially extending first section may have thesame or different dimensions as the axially extending second section.The radially and axially extending sections may have constant or varyingwidths. For example, the radially extending section may taper inwardfrom the radial opening on the delivery device shaft to its innerterminal end.

In another embodiment, the delivery device shaft may include a sheathfor partially or substantially surrounding the axial opening to theL-slot. The sheath may partially extend over the axial opening L-slot orform a flap overhanging the axial opening to impede an association loopfrom unhooking/disassociating from the L-slot.

Any delivery device may be modified to include an association structureas described above. For example, any delivery device configured forsuprapubic, pre-pubic, transvaginal, or transobtural delivery of animplant may employ an association structure of the invention.

BRIEF DESCRIPTION OF THE DRAWINGS

The following figures depict illustrative embodiments of the inventionin which like reference numerals refer to like elements. These depictedembodiments may not be drawn to scale and are to be understood asillustrative of the invention and not as limiting in any way.

FIG. 1 depicts a sling assembly including association loops according toan illustrative embodiment of the invention.

FIG. 2 depicts an association loop affixed into a dilator assemblyaccording to an illustrative embodiment of the invention.

FIG. 3 depicts an association loop affixed into a dilator assemblyaccording to a alternative illustrative embodiment of the invention.

FIG. 4 depicts an association loop having a biasing mechanism andaffixed into a dilator assembly according to another alternativeillustrative embodiment of the invention.

FIG. 5 depicts an association loop having an alternative shape, abiasing mechanism and affixed into a dilator assembly according toanother illustrative embodiment of the invention.

FIG. 6 depicts an association loop having a twisted portion affixed intoa dilator assembly connected to an end of a sling assembly according toanother illustrative embodiment of the invention.

FIG. 7 depicts an association loop affixed in a dilator assembly andincluding an extension portion for positioning the association loop adesired distance away from the tissue dilating portion of the dilatorassembly according to another illustrative embodiment of the invention.

FIG. 8 depicts an association loop affixed into a dilator assembly andformed from a braided tubular filament according to another illustrativeembodiment of the invention.

FIG. 9 depicts an association loop affixed into a dilator assembly andincluding a coating according to another illustrative embodiment of theinvention.

FIG. 10 shows a sling assembly end with a sleeve attached to anassociation loop via a dilator assembly according to an illustrativeembodiment of the invention.

FIG. 11 shows a sling assembly end with a sleeve attached to anassociation loop via a dilator assembly according to anotherillustrative embodiment of the invention.

FIG. 12 shows a side view of an association loop affixed into a dilatorassembly according to another illustrative embodiment of the invention.

FIG. 13 shows an L-slot formed in a distal portion of a delivery deviceshaft according to an illustrative embodiment of the invention.

FIG. 14 shows an L-slot formed in a distal portion of a delivery deviceshaft and including an indentation and a protuberance for facilitatingretention of an association loop according to an illustrative embodimentof the invention.

FIG. 15 shows an L-slot formed in a distal portion of a delivery deviceshaft wherein a radially extending leg of the L-slot is wider than anaxially extending leg for facilitating ease of insertion into theradially extending leg and for facilitating retention of an associationloop in the axially extending leg according to another illustrativeembodiment of the invention.

FIG. 16 shows an L-slot formed in a distal portion of a delivery deviceand having a tapered axially extending leg for facilitating retention ofan association loop in that leg according to another illustrativeembodiment of the invention.

FIG. 17 shows another illustrative L-slot formed in a distal portion ofa delivery device wherein the radially extending leg has a tapered shapefor facilitating insertion of an association loop, and the axiallyextending leg has a narrowed width to facilitate retention of theassociation loop according to another illustrative embodiment of theinvention.

FIG. 18 shows a T-shaped structure formed in a distal portion of adelivery device for engaging with an association loop according toanother illustrative embodiment.

FIG. 19 shows the L-slot structure of FIG. 13 including a sheathpartially extending over the opening to the radially extending legaccording to an illustrative embodiment of the invention.

FIG. 20 shows the L-slot structure of FIG. 13 including anotherillustrative embodiment of a sheath that partially extends over theopening to the radially extending leg.

FIG. 21 shows the L-slot structure of FIG. 13 including anotherillustrative embodiment of a sheath that partially surrounds the L-slotstructure.

FIG. 22 shows the L-slot structure of FIG. 13 including anotherillustrative embodiment of a sheath that includes a flap portion thatextends into the radially extending leg of the L-slot.

FIGS. 23A shows an association loop at the end of a sling assembly priorto association with an L-slot on the end of a delivery device accordingto an illustrative embodiment of the invention.

FIG. 23B shows an association loop of a sling assembly hooked into theaxially extending leg of the L-slot on the end of a delivery deviceaccording to an illustrative embodiment of the invention.

FIG. 24 depicts a ball-shaped association member extending from adilator assembly according to another illustrative embodiment of theinvention.

FIG. 25 shows the ball-shaped association member of FIG. 28 associatingwith a corresponding illustrative structure on a delivery device forplacement of an implantable sling.

FIG. 26 depicts a sling delivery system including a delivery deviceparticularly sized and shaped for suprapubic sling delivery and havingany suitable slot at a distal end according to an illustrativeembodiment of the invention, and employable with any of the illustrativeembodiments of the association loops of FIGS. 1-11.

FIG. 27 shows another illustrative delivery device particularly sizedand shaped for transobtural placement of an implantable sling and havingany suitable slot at a distal end, and employable with any of theillustrative embodiments of the association loops of FIGS. 1-11.

FIGS. 28A-28C show another illustrative delivery device alsoparticularly sized and shaped for transobtural placement of animplantable sling and having any suitable slot at a distal end, andemployable with any of the illustrative embodiments of the associationloops of FIGS. 1-11.

ILLUSTRATIVE DESCRIPTION

The invention relates to cooperating structures on one or more ends of amedical implant assembly and on an end of a delivery device to enable amedical operator to associate the medical implant assembly with thedelivery device so that the medical operator may deliver the implant toan anatomical location in a patient's body. Preferably, the implantassembly is a sling assembly including a sling for treating urinaryincontinence, and the anatomical site is in the periurethral tissue ofthe patient (e.g. under a bladder neck or mid-urethral location).

Without limitation, examples of features of various sling configurationsthat may be employed with illustrative embodiments of the invention aredisclosed in U.S. Ser. No. 10/092,872, entitled “Medical slings,” U.S.Ser. No. 10/640,838, entitled “Medical implant,” U.S. Ser. No.10/641,170, entitled “Medical slings,” U.S. Ser. No. 10/641,192,entitled “Medical slings,” U.S. Ser. No. 10/918,123, entitled “SurgicalSlings,” the entire contents of all of which are incorporated herein byreference.

Additionally, examples of features of various delivery systems that maybe employed with illustrative embodiments of the invention include,without limitation, those delivery systems configured for supra-pubic,pre-pubic, transvaginal, and/or transobtural procedures. Again, withoutlimitation, examples of features of dilators, slings, sling assemblies,delivery devices and implantation approaches that may be employed withillustrative embodiments of the invention are disclosed in U.S. Pat. No.6,666,817, entitled “Expandable surgical implants and methods of usingthem,” U.S. Pat. No. 6,669,706, entitled “Thin soft tissue surgicalsupport mesh,” U.S. Pat. No. 6,375,662, entitled “Thin soft tissuesurgical support mesh,” U.S. Pat. No. 6,042,592, entitled “Thin softtissue surgical support mesh,” U.S. Ser. No. 10/015,114, entitled“Devices for minimally invasive pelvic surgery,” U.S. Ser. No.10/774,826, entitled “Devices for minimally invasive pelvic surgery,”U.S. Ser. No. 10/093,398, entitled “System for implanting an implant andmethod thereof,” U.S. Ser. No. 10/093,498, entitled “System forimplanting an implant and method thereof,” U.S. Ser. No. 10/093,371,entitled “System for implanting an implant and method thereof,” U.S.Ser. No. 10/093,424, entitled “System for implanting an implant andmethod thereof,” U.S. Ser. No. 10/093,450, entitled “System forimplanting an implant and method thereof,” U.S. Ser. No. 10/094,352,entitled “System for implanting an implant and method thereof,” U.S.Ser. No. 10/631,364, entitled “Bioabsorbable casing for surgical slingassembly,” U.S. Ser. No. 10/641,376, entitled “Spacer for sling deliverysystem,” U.S. Ser. No. 10/641,487, entitled “Systems, methods anddevices relating to delivery of medical implants,” U.S. Ser. No.10/642,395, entitled “Systems, methods and devices relating to deliveryof medical implants,” U.S. Ser. No. 10/642,397, entitled “Systems,methods and devices relating to delivery of medical implants,” U.S.patent application Ser. No. 10/642,365, entitled “Systems, methods anddevices relating to delivery of medical implants,” U.S. Ser. No.10/832,653, entitled “Systems and methods for sling delivery andplacement,” U.S. patent application Ser. No. 10/939,191, entitled“Devices for minimally invasive pelvic surgery,” U.S. patent applicationSer. No. 10/957,926, entitled “Systems and methods for delivering amedical implant to an anatomical location in a patient,” U.S.Provisional Application No. 60/569,300, entitled “Systems and methodsfor delivering a medical implant to an anatomical location in apatient,” and U.S. Provisional Application No. 60/508,600 entitled“Systems and methods for delivering a medical implant to an anatomicallocation in a patient,” the entire contents of all of which areincorporated herein by reference.

FIG. 1 depicts a sling assembly 10, which includes an association loop 1attached via a dilator 5 to an end of a sleeve 9 holding an implantablesling 11. Another association loop 3 attaches via a dilator 7 to theother end of the sleeve 9. The association loop 1 is shown assubstantially in the plane of the sleeve 9. It is to be understood thatthe association loop 1 may be configured at other angles relative to theplane of the sleeve 9. For example, the associate loop 3 may be in aplane substantially orthogonal to the plane of the sleeve 9.Furthermore, the association loops 1 and 3 may be substantially in thesame plane or in different planes. In certain embodiments, theassociation loops 1 and 3 may be fixed at a specific angle relative tothe plane of the sleeve 9, for example, in a plane about 30, 45, 60 or90 degrees to the plane of the sleeve 9. In other embodiments, theassociation loops 1 and 3 may be configured to rotate 360 degreesrelative to the plane of the sleeve 9.

In alternative embodiments, the association loop 1 can be configuredinto any shape that allows it to cooperate with a complementarystructure located on a delivery device. For example, the associationloop 1 can have an irregular shape or it can be, for example,substantially circular, teardrop, triangular, square, rectangular or acombination of these shapes. In one example, the association loop 1 isopen, for example, forms a hook or forms an eyelet. In another example,the loop is closed. The loop can be resilient, rigid, semi-rigid, and/orflexible. Preferably, the loop is flexible enough to deform as it ispushed/pulled through tissue, but rigid enough to maintain its integrity(i.e., not break) against the pushing/pulling force. The associationloop 1 can be made from any suitable material, such as a wire or asuturing material. Preferably the loop is made of a biocompatiblematerial that allows for the resiliency, flexibility and rigiditydescribed above, for example, metal, plastic, polymers, etc.

The association loop 1 can also be of any suitable size, for example,the association loop 1 can have a diameter that is just large enough toslide over an end of a delivery device or a delivery needle. Theassociation loop 1, when it is configured to have such a diameter, helpsto maintain the cooperation between the association loop 1 and thedelivery device during placement of the sling. The association loop 1may also be sized to be long enough such that when hooked on to acomplementary structure near a distal end of a delivery device andpulled by a user with enough force away from the distal tip of adelivery device, the association loop 1 swings about the tip of thedelivery device for removal.

The association loop can be formed from a single stranded filament orcan be formed from a multi-stranded filament. The multiple strands maybe braided or twisted together. The use of multiple strands to form theassociation loop 1 is preferred because a multi-stranded loop mayprovided more structural flexibility than an association loop formedfrom a single strand.

Any suitable adaptor may be used to attach the association loop 1 with aparticular medical implant assembly. For example, in FIG. 1, the slingassembly 10 employs the dilators 5 and 7 for attaching the associationloops 1 and 3, respectively, to the ends of the plastic sleeve 9. Morespecifically, the knitted mesh 11 resides, at least partially, withinthe plastic sleeve 9. An opening 8, located at a midpoint of a topportion of the plastic sleeve 9, exposes the entire width of the knittedmesh 11. The knitted mesh 11 may be made entirely of polypropylene, maybe approximately 1 cm in width and 45 cm in length, and terminates atfree ends. The knitted mesh 11, including both free ends, does notconnect to the plastic sleeve 9 or anything else. This feature enables amedical operator to pull on the ends of the plastic sleeve 9 duringsling placement, for example, via the dilators 5 and 7, the associationloops 1 and 3, and/or the delivery devices, without risk of stretching,curling or otherwise deforming the knitted mesh 11.

A tabbed spacer (not shown) is located at a midpoint of a bottom side ofthe plastic sleeve 9, and encloses a looped portion of the bottom sideof the plastic sleeve 9. The tabbed spacer can be used duringimplantation as a visual aid to placement of the implant assembly. Thetabbed spacer also engages the looped portion of the bottom side of theplastic sleeve 9 and prohibits the plastic sleeve 9 from sliding off, orotherwise being removed from, the knitted mesh 11 during implantassembly placement. The tabbed spacer must be cut to enable the plasticsleeve 9 to slide off the knitted mesh 11. This feature ensures that theplastic sleeve 9 cannot be removed simply by applying a pulling force,such as that applied to the implant assembly ends by a medical operatorduring implant assembly placement. After the sling assembly 10 ispositioned within the patient, a cut is made through the center of thetabbed spacer, and thus through the looped portion of the bottom side ofthe plastic sleeve 9. The plastic sleeve 9 is then slid off of theknitted mesh 11, out of the body of the patient, and discarded, alongwith the dilators 5 and 7.

FIG. 2 depicts dilator assembly 20 including an association loop 22according to an illustrative embodiment of the invention. In thisembodiment, the association loop 22 is formed from a multi-strandedtwisted filament. A pin 29 is used to size and shape the associationloop 22. The filament ends 22 a and 22 b are inserted through an axiallyextending channel 26 into a crimp tube 24. A second crimp tube isdepicted in outline to demonstrate that the crimp tube 24 may be placedat any location along the filament ends 22 a and 22 b. The crimp tube24, once compressed (i.e., crimped), serves to lock the filament ends 22a and 22 b together to form the loop 22. The filament ends 22 a and 22b, including the crimp tube 24 may affixed into the dilator 28 in anysuitable manner. For example, the dilator 28 may be injection moldedaround the filament ends 22 a and 22 b, and/or the crimp tube 24. Thefilament ends 22 a and 22 b and the crimp tube 24 can be permanently orremovably positioned within the dilator 28. For example, the filamentends 22 a and 22 b may be permanently attached to the dilator 28 by, forexample, molding or gluing the dilator 28 over the filament ends 22 aand 22 b and the crimp tube 24.

In this embodiment, the loop ends 22 a and 22 b are shown to be entirelyinside the dilator 28 and a portion of the crimp tube 24 is locatedexternal to the dilator 28. As depicted in FIG. 2, the loop 22 extendsfrom the tapered end 28 a of the dilator 28.

In one example, the length of a dilator is preferred to be greater thanabout 0.3 inches long to aid in passage through a patient's body.However, in other embodiments, it may be less than about 0.3 inches. Inother embodiments, the dilator length is between about 0.2 inches andabout 10.0 inches. In preferred embodiments, the dilator length isbetween about 0.3 inches and about 2.0 inches. One advantage of thelonger dilators, for example, dilators having a length greater thanabout 2.0 inches, is that the dilators can be used to untwist the slingassembly before pulling the plastic sleeve and knitted mesh into thebody.

A dilator may include a conical portion and a straight portion. Thestraight portion has a constant diameter. The conical portion has adiameter that varies and decrease from the diameter of the straightportion. Preferably, the diameter of the straight portion of a dilatorwill be about 0.25 inches. However, the diameter of the straight portionof a dilator may be from about to 0.1 about 0.8 inches.

FIG. 3 depicts an alternate embodiment of a dilator assembly 30including a tissue dilator 38 and an association loop 32 according toanother illustrative embodiment of the invention. As in the case of theillustrative embodiment of FIG. 2, the filament ends 32 a and 32 b ofthe association loop 32 pass through a crimp tube 34. As an improvementover the FIG. 2 embodiment, the crimp tube 34 includes a ball section 34b and a shank section 34 a. The shank section 34 a is crimped to ensurefilament retention, while the ball section 34 b creates furtherresistance against the association loop 32 being inadvertently pulledout of the dilator 38. The association loop 32 and the crimp tube 34 maybe insert-molded into the dilator 38. A pin 39 is used to size and shapethe association loop 32.

FIG. 4 shows an alternative illustrative embodiment of a dilatorassembly 40 having an extendable association loop 46 according to theinvention. The dilator assembly 40 includes a tissue dilator 41 having aleading end 42 and a trailing end 43. The leading end 42 is the end ofthe dilator that is first inserted into a patient's tissues, and istapered to increase the size of a tunnel formed initially by a shaft ofa delivery device. The increased tunnel size eases the passage of asling assembly or other medical implant. As in the case of previouslydisclosed embodiments, an association loop 46 extends out of the leadingend 42 of the dilator 41. As depicted, the dilator 41 includes a channel44 extending axially through the dilator 41 from the leading end 42 toan intermediate shoulder 47, and a channel 45 extending axially throughthe dilator 41 from the intermediate shoulder 47 to the trailing end 43.The channels 44 and 45 are in fluid communication with each other, withthe channel 44 having a reduced diameter relative to the channel 45, andwith the reduced diameter being delineated by the intermediate shoulder47. A biasing element, such as the spring 48, is seated within thechannel 45, with a leading end 48 a abutting the shoulder 47. As in thecase of FIGS. 2 and 3, the association loop 46 is formed from a filamenthaving two terminal ends 46 a and 46 b. The terminal ends 46 a and 46 bthread through the channel 44 and the spring 48. A crimp tube 49interfits over the filament ends 46 a and 46 b and is crimped forretention. The crimp tube 49 then concentrically interfits into thespring 48. As shown, the crimp tube 49 includes a radially extending rim49 a. The radially extending rim 49 a is wider than the inner diameterof the spring 48 and abuts the trailing spring end 48 b. FIG. 4 showsthe spring 48 in an uncompressed state.

In operation, in response to pulling on the association loop 46, theradially extending rim 49 a of the crimp tube 49 engages the trailingend 48 b of the spring 48 and causes the spring 48 to compress, alsocausing an additional length of the filament forming the associationloop 46 to extend out of the leading end 42 of the dilator 41. Extendingadditional filament out of the dilator 41 effectively increases the sizeof the association loop 46. This type of spring biasing enables theassociation loop 46 to expand over a particular delivery device featureduring association with the delivery device, and then to retract toimpede the association loop 46 from becoming disassociated with thedelivery device during implantation.

A crimp tube as depicted in FIGS. 2, 3, and 4 may have an outer diameterof about 0.5 mm, 1 mm, or about 2 mm larger than the association loopends. The crimp tube may have a constant or varying diameter and mayinclude other structural features, such as a shoulder, a ledge, anindent, and/or a slot. When used in combination with a spring, the crimptube and spring are sized such that at least a portion of the crimp tubeis larger than the inner diameter of the spring to enable the crimp tubeto engage and compress the spring in response to a pulling force on theassociation loop.

FIG. 5 depicts another embodiment of an association loop and dilatorassembly 50 including a crimp tube 54, a spring 56, a dilator 52, and anassociation loop 58 where the association loop 58 include bends 58 a and58 b just distal and external to the dilator 52. The dilator assembly 50operates in a substantially similar fashion to the previously discusseddilator assembly 40, the difference being primarily in the configurationof the crimp tube 54 and the inclusion of bends 58 a and 58 b in theassociation loop 58. Rather than engaging the biasing spring 48 with aradially extending rim 49 a, the crimp tube 54 has an increased diameteralong its entire length. The crimp tube 54 has a diameter wider than theinner diameter of the spring 56 and, thus, enables it to be positionedwith its leading end 54 a abutting the trailing end 56 b of the spring56. In operation of this embodiment, pulling on the association loop 58causes the leading end 54 a of the crimp tube 54 to engage with thetrailing end 56 b of the spring 56 also causing the spring 56 tocompress. Furthermore, the compression of the spring 56 allows anadditional length of loop filament to extend out of the dilator 52. Thebends 58 a and 58 b inhibit the association loop 58 itself from beingretracted back into the dilator 52. The bends 58 a and 58 b may alsomaintain the spring 56 and the crimp tube 54 within a channel 51 of thedilator 52 during assembly, as the trailing end of the dilator 52 may beleft open. In alternative embodiments, the trailing end of the dilator52 may be closed and the dilator 52 may enclose the crimp tube 54 withinthe cavity 51. It is to be understood that the configuration of thecrimp tube 54 and the spring 56 may be employed in combination with anassociation loop having any of the various shapes as described herein.

FIG. 6 depicts another embodiment of a dilator assembly 60. In thisembodiment, the filament forming an association loop 66 twists arounditself subsequent to extending out of the dilator 62 to form a twistedsection 64. The illustrative twisted section 64 has a length X, whichmay be increased by additional twisting or decreased by reducedtwisting. As can be seen, increased twisting also reduces the size ofthe association loop 66, while reduced twisting increases the size ofthe association loop 66. Additionally, the twisting can be used tochange the orientation of the association loop 66 relative to theorientation of the sleeve 61 and the sling 63 contained within thesleeve 61. The twisted section 64 of distance X can be bent to positionthe dilator 62 in front of a shaft tip of a delivery device to provide asmooth pull-through due to the inline profile of the shaft and dilator.This embodiment provides an easily used mechanism for forming anassociation loop 66 having a predetermined size and a predetermineddistance X from the leading end of the dilator 62. The twisted section64 may add a distance X between the sleeve 61 and the association loop66, without the need for changing the length of the dilator 62.

FIG. 7 depicts another illustrative embodiment of an association loop 74formed into a dilator 72. In this embodiment, the dilator 72 has threesections, a trailing section 72 a, an intermediate conical section 72 b,and a leading section 72 c. The intermediate conical section 72 bextends from the trailing section 72 a. The leading section 72 cterminates in a conical tip 72 d and extends from the intermediatesection 72 b. The association loop 74 extends from the conical tip 72 dof the leading section 72 c much in the same way as the association loop66 extends from the dilator 62 in FIG. 6. One function of the leadingsection 72 c is to space the association loop 74 a distance X from theend of the intermediate conical section 72 b, without the need for anyfilament twisting.

In the depicted embodiment, the filament ends 74 a and 74 b are embeddedin the dilator 72 in any suitable fashion, including any of thosedescribed herein. In some configurations, the leading section 72 c maybe substantially hollow or solid, and may be substantially rigid ordeformable. In some configurations, the leading section 72 c may beformed integral with the intermediate section 72 b or may be a separatecomponent that interfits over the association loop 74 to adjust the sizeof the association loop 74 and/or space it a distance X from the end ofthe intermediate section 72 b.

FIG. 8 depicts another dilator assembly 80 having an association loop 84affixed at a leading end of a dilator 82. A unique aspect of thisembodiment is that the association loop 84 is formed from amulti-stranded filament. In the depicted embodiment, the multiplestrands are braided to form a hollow tube. When the braided associationloop 84 is tensioned, the inner and outer cross-sectional diameters ofthe loop filament become smaller, while the length of the loop 84increases. The association loop 84 and dilator 82 may be associated withany complementary structure on a delivery device, such as any of thosedescribed herein. One advantage of this configuration, referring also toFIGS. 13-23B, is that the association loop 84 may be tensioned duringinsertion into a suitable slot or notch. Such tensioning causes thediameter of the loop filament to decrease and more easily fit into thenotch or slot. Another advantage is that once tensioning is removed, theloop filament tends to expand back to its steady state diameter, thusimpeding it from easily sliding out of a suitably sized notch or slot ina delivery device.

FIG. 9 depicts another illustrative embodiment of dilator assembly 90including an association loop 94 according to an illustrative embodimentof the invention. As in the previously discussed embodiments, theassociation loop 94 is affixed in some suitable fashion within thedilator 92. In the depicted example of FIG. 9, the association loopfilament may be single or multi-stranded. If multi-stranded, it may beconfigured in any suitable manner, including the above describedtwisted, braided, and/or hollow tubular manner. As an additionalfeature, the loop filament of FIG. 9 includes a coating 96. The coating96 may be formed, for example, from a suitable elastic material, such assilicone.

According to one configuration, the diameter of the coated loop 94 issized to be smaller than the outer diameter of a shaft of a deliverydevice. In operation, as the loop 94 is placed over a tapered distaltip, as shown in FIG. 13, the compressible coating 96 on the associationloop 94 contracts to allow the association loop 94 to interfit over thedistal end of a delivery device shaft. According to another illustrativeexample, the coated association loop 94 has a cross-sectional diameterthat is larger than the width of a slot on a delivery device shaft. Inthis example, and as in the case of the FIG. 8 braided embodiment, theassociation loop filament can compress to interfit into the slot. Then,the tendency for the compressed coating to return to its normaluncompressed state acts to impede, and in some configurations prohibit,the association loop 94 from falling out of the slot and becomingdisassociated with the delivery device.

FIG. 10 shows a dilator assembly 102, including an association loop 104of the type described above, affixed to an end of a sling assembly 106according to an illustrative embodiment of the invention. As shown, theexemplary sling assembly 106 includes a mesh sling 108 and a protectivesleeve 110. The mesh sling 108 is free floating in that it does notattach to anything, including the protective sleeve 110 or the dilatorassembly 102. The end 114 of the sleeve 110 wraps around and isheat-bonded to a substantially cylindrical trailing portion 112 of thedilator assembly 102. To heat bond the sleeve end 114 to the dilatorportion 112, the plane of the association loop 104 is first oriented tothe plane of the sleeve 110, for example, either substantially parallel,perpendicular, or any other any angle, to the sleeve 110. The sleeve end114 is flattened and the dilator portion 112 is placed on top of thesleeve end 114. The sleeve end 110 is then wrapped around the dilatorportion 112 to form a “U” or “C” shape, and heat is applied to bond thesleeve end 114 onto the surface of the dilator portion 112. In analternative embodiment, a piece of heat shrink tubing can be placed overthe sleeve end 114 and the dilator portion 112 prior to the applicationof heat to bond the sleeve 110 to the dilator assembly 102. It should benoted that any suitable method may be used to attach the sleeve to thedilator assembly, for example, heat bonding, gluing, stapling,stitching, etc.

In other embodiments, the sleeve end may have a width larger than thecircumference of the dilator. The sleeve end may be wrapped around thedilator and the sides of the sleeve end may overlap each other. Thewidth of the sleeve end may also be reduced, for example, by folding ortrimming, such that the sleeve end encircles the dilator fully at mostonce, and without overlap. It is preferred that the attachment of thesleeve end to the dilator not substantially add to the size or profileof the dilator as a smaller profile is perceived to be safer duringdelivery of an implantable sling assembly.

FIG. 11 depicts another method of bonding a sleeve end 115 to a dilatorassembly 116. Instead of just wrapping the sleeve end 115 around thedilator trailing portion 113, the dilator trailing portion 113 is firstinserted into the sleeve end 115. More specifically, the plane of theassociation loop 118 is first oriented to the plane of the sleeve 119,for example, either substantially parallel, perpendicular, or any otherany angle, to the sleeve 119. The trailing portion 113 of the dilatorassembly 116 is then inserted into the sleeve end 115. The sleeve end115 is then pulled tightly around the dilator trailing portion 113, andheat is applied to bond the sleeve end 115 to the surface of the dilatortrailing portion 113. In an alternative embodiment, a piece of heatshrink tubing is then inserted over the sleeve end 115 and heated tobond the sleeve end 115 to the surface of the dilator trailing portion113.

Although the preferred illustrative embodiments of FIGS. 10 and 11depict the sling assembly including a protective sleeve and the sling asbeing free floating, this need not be the case. In other illustrativeembodiments, the protective sheath may be eliminated and the sling endsbe bonded directly to the dilator assemblies. In other illustrativeembodiments, the sling may be attached to the protective sleeve in anysuitable fashion.

Additionally, any suitable sleeve and sling assemblies or slings knownin the art can be used with the invention. For example, a sling meshhaving tangs or projections that extend laterally from the edges of thesling along at least a portion of the length of the sling can be used.It is preferred that when the sling is placed in the body, the sling canlie somewhat flat to allow tissue ingrowth and the tanged portion of thesling to grip the tissue. In the embodiment where the sleeve or sling isthermobonded to the dilator, the dilator and the sling or sleeve arepreferably made of a material which is compatible for thermobonding toachieve the maximum bond strength. An example of such a compatiblethermobonding material is polyethylene. In an alternative embodiment,the sling or sleeve is glued to the dilator, for example, usingcyanoacrylate. When gluing with cyanacrylate, the dilator and the sleeveare preferably made of a plastic material such as nylon. Suitablesleeves and slings are disclosed in the documents listed herein aboveand incorporated by reference in their entirety.

The invention further includes methods of producing a mating structure,such as an association loop, on an implant assembly. FIG. 12 depictsanother illustrative dilator assembly 120 including an association loop122 formed into a tissue dilating structure 124. In addition toemploying a crimp tube 126, such as the metal crimp tubes previouslydiscussed, this illustrative configuration also bends the terminal ends122 a and 122 b of the association loop filament at an angle to alongitudinal axis of the crimp tube 126. In a similar fashion to theembodiments of FIGS. 4 and 5, the dilator 124 includes two axiallyextending channels 127 and 129 in fluid communication with each otherand interfacing at an intermediate shoulder 128.

According to one illustrative process, the association loop is flattedand interfitted through the crimp tube 126 as shown in FIG. 12. Theleading end 123 of the flatted association loop 122 is then insertedinto the channel 127 via the channel 129 at the trailing end 124 a ofthe dilator 124. As the leading end 123 of the association loop 122extends through an opening at the leading end 124 b of the dilator 124,the leading end 126 a of the crimp tube 126 abuts the shoulder 128,which stops the crimp tube 126 from passing into the channel 127. Atthis point, the excess ends 122 a and 122 b may be trimmed or cut offall together. Leaving some remnant of the ends 122 a and 122 b may bedesirable to provide additional protection against the association loop122 pulling out of the dilator 124.

Subsequent to the above described assembly, the association loop 122 canbe expanded and shaped as desired. Preferably, the loop is shaped suchthat it cannot slip back into the dilator 124. In some configurations,neither the crimp tube 126 nor the association loop filament is affixedrotationally in the dilator 124. This feature enables the associationloop 122 to rotate relative to the dilator 124, allowing the medicaloperator to twist and untwist a sling assembly while the loop 122 isassociated with a delivery device.

According to another feature, the invention provides an association loopexpansion tool of the type depicted at 129. To expand the associationloop 122, the tip 129 a of the loop expansion tool 129 is passed throughthe flatted association loop 122 to open it to a desired degree. In thisembodiment, where the expansion tool 129 is conical in shape, an ovallike association loop 122 is produced. However, the tool 129 can haveany preferred profile or cross-section of choice, for example,triangular or rectangular to provided association loops of variousshapes. One advantage of the conical design of the tool 129 is that itenables the association loop 122 to be opened to whatever degree isdesired by the medical operator.

In an alternative embodiment, an association loop 122 and dilatorassembly 120 can also be produced by inserting the two ends 122 a and122 b of a flatted loop filament into the leading end 124 b of thedilator 124. A crimp tube 126 can then be inserted onto the filamentends 122 a and 122 b and crimped at a given length. In this example, thefilament ends 124 a and 124 b extend in a trailing direction and are notbend to form a T. The flatted association loop 122 and the dilator tube126 are then pulled back towards the leading end 124 b of the dilator124 where the loop is formed to a preferred shape.

In another illustrative embodiment, a cavity of a dilator can be shapedto a desired configuration such as an oval cross-sectional configurationto prevent the crimped filament from rotating within the dilator and,thus, preventing the association loop from rotating outside the dilator.In another alternative embodiment, a cavity can be tapered such thatwhen the crimp tube is pulled into the cavity, the cavity interfereswith the crimp tube to prevent rotation of the association loop relativeto the dilator.

The association loops and dilator assemblies depicted in FIGS. 1-12 havebeen described as having a generally oval shape. However, this need notbe the case and the association loops of the invention may have anysuitable shape, including without limitation, circular, rectangular,triangular, or any other suitable polygonal or curved shape.Additionally, the association loops described herein may be used incombination with any suitable complimentary mating structure located ona delivery device, for example, such as an appropriately sized andshaped slot in a distal end of a shaft of a delivery device. In thefollowing illustrative description and accompanying drawings, theassociation loop 1 is used to illustrate the interaction of anassociation loop with a suitable mating structure located on a deliverydevice. Only the portion of the association loop 1 within the matingstructure is depicted, e.g., a cross-sectional view of the associationloop 1. Although the association loop 1 may be shown contacting thewalls of the channels of the delivery devices, it is understood that theassociation loop may be sized smaller or larger than the width of thechannels of the delivery devices, and that any suitable association loopmay be employed, including without limitation, any of the illustrativeassociation loops described herein.

A delivery device may be configured with a mating structure, such as aslot, which can cooperate with an association loop as described above.The slot can be positioned at any location along the delivery device,but is preferably located close to the distal tip of the deliverydevice. Some illustrative suitable delivery devices are disclosed in thedocuments listed herein above and incorporated by reference in theirentirety. In one embodiment, the delivery device includes a shaft thatcan be used to penetrate tissue or fascia. The shaft can be made ofrigid material or malleable material. The shaft can be pre-bent suchthat it defines a configuration that has one or more curves in a planeor the shaft can have one or more curves on multiple planes. Preferably,the delivery device has an opening into which the association loop canbe inserted. In one illustrative embodiment, the opening is a slotdefined by a channel having radially disposed and longitudinallydisposed sections/legs. The slot can have any shape and can besubstantially smooth or can include one or more dimples, grooves,protuberances and/or indentations or other irregularities, formed eitherduring the manufacture of the slot or by attaching an implant to theslot wall. Preferably, the slot is shaped such that it impedes, and insome cases prohibits, the loop from easily unhooking and disassociatingfrom the slot.

FIG. 13, for example, depicts an L-shaped slot 132 positioned near adistal end 130 of a delivery device shaft 134. The L-shaped slot 132 isformed from a first channel 133 extending radially into the shaft 134,and a second channel 135 extending distally along the axis 136 of theshaft 134 from an inner terminal end 133 a of the first channel 133. Anassociation loop, such as the associate loop 1 of FIG. 1, can slideradially into the opening 133 b of the first channel 133 and along thefirst channel 133 to the inner terminal end 133 a. The association loop1 can then slide distally along the second channel 135 to the mostdistal end 135 a of the second channel 135 to hook one end of theimplant assembly 10 of FIG. 1 onto the distal end 130 of the shaft 134.During a sling placement procedure, this process may be repeated withthe second association loop 3 and the same or a second similar deliverydevice.

According to the illustrative embodiment of FIG. 13, the first radiallyextending channel 133 may be about 1 mm, 1.5 mm, 2 mm, or about 2.5 mmin length and about 0.5 mm, 0.75 mm, 1 mm, or about 1.5 mm in width, andthe second axially extending channel 135 may be about 3 mm, 4 mm, 5 mmor about 6 mm in length and about 0.5 mm, 0.75 mm, 1 mm, or about 1.5 mmin width. The shape and/or dimensions (e.g., width, length or diameter)of the slot 132 may be varied to suit the dimensions or intendedorientation of the association loop on the implant assembly.

An advantageous feature of the L-shaped slot 132 is that the associationloop 1 slides easily into the first channel 133 and remains free toslide along the second channel 135. When slid to a proximal mostposition 133 a in the second channel 135, the association loop 1 may beslid radially out of the first channel 133 to unhook the associationloop 1 and thus, the implant assembly 10, from the shaft 134 with aminimum of effort. Alternatively, in response to pulling the shaft in aproximal direction (a motion typically employed in a abdominallyinitiated sling implantation procedure when withdrawing a deliverydevice to pull an end of a sling assembly up through the abdomen via anincision in the vaginal wall of a patient), the distally extendingorientation of the second channel 135 causes the association loop 1 toslide to the distal most position 135 a in the L-shaped slot 132. Thistends to maintain the association loop 1, and thus the implant assembly10, hooked onto the L-shaped slot 132 during withdrawal of the shaft 134in a proximal direction.

FIG. 14 depicts an alternate embodiment of an L-shaped slot 142 formedin a distal end 144 of a shaft 146 of a delivery device. The L-shapedslot 142 is similar to the L-shaped slot 132 in that it includes a firstradially extending channel 143 and a second axially extending channel145. As an additional feature, the radially extending channel 143includes an indentation 147 extending axially in a proximal direction.The indentation is sized and shaped to seat the association loop 1 toimpede, and in some cases prohibit, it from sliding radially out of thechannel 143. As a further feature, the axially extending channel 145includes a width narrowing protuberance 149 located at its proximal mostend. The protuberance 149 is sized to impede, and in some configurationsto prohibit, the association loop 1, subsequent to insertion into thechannel 145, from sliding in a proximal direction along the channel 145sufficiently far to enable it to enter the radially extending channel143. In this way, the protuberance 149 also impedes, and in someconfigurations prohibits, the association loop 1 from becoming unhookedfrom the shaft 146.

FIG. 15 depicts another illustrative embodiment of an L-shaped slot 150in a distal end 154 of a shaft 156. As in the previously discussedembodiments, the slot 150 includes a radially extending channel 151 andan axially extending channel 152. A feature of the illustrativeembodiment of FIG. 15 is that the axially extending channel 152 has awidth that is both smaller than the width of the radially extendingchannel 151 and less than a normal uncompressed diameter of the filamentforming the association loop 1. In operation, the association loop 1slides freely into the radially extending channel 151, but is compressedwhen slid into the axially extending channel 152. This compressioncauses an increased friction between the association loop 1 and theaxially extending channel 152, which tends to maintain the associationloop 1 within the axially extending channel 152.

FIG. 16 depicts a further alternative embodiment of an L-shaped slot 160located at the distal end 162 of a delivery device shaft 164. A featureof this embodiment is that the axially extending channel 168 tapersinward as it extends distally. The taper reduces the width of thechannel 168 sufficiently near its distal end 168 a to compress thefilament of the association loop 1 when the association loop 1 is pulleddistally toward the tapered distal end 168 a of the second channel 168.This tends to inhibit the association loop 1 from sliding proximallyalong the channel 168 and becoming unhooked from the shaft 164.

The resiliency and flexibility of the material forming and/or coatingthe association loop 1 contribute to the force holding the associationloop 1 in place near the distal end 168 a of the tapered second channel168. For example, an association loop 1 formed from a strand of metalwire may not easily compress and become lodged in the tapered secondchannel 168. However, an association loop 1 formed from multiple strandsof wire and/or coated with a flexible or resilient material, such as apolymer, may compress and lodge more securely in the tapered secondchannel 168. This type of association loop may require more force topull the association loop out of the channel 168.

FIG. 17 depicts another alternative embodiment of an L-shaped slot 170formed in a distal end 176 of a delivery device shaft 178. As in thepreviously discussed embodiments, the slot 170 includes a radiallyextending channel 172 and an axially extending channel 174. One featureof this illustrative embodiment is that the opening 173 to the radiallyextending channel 172 is enlarged for easy insertion of the associationloop 1. More specifically, the wall 172 a of the radially extendingchannel 172 tapers outward to create to the enlarged opening 173.According to the illustrative embodiment, the width of the radiallyextending channel 172 at all locations is larger than the outsidediameter of the association loop filament. According to another featureof this embodiment, in a similar fashion to the axially extendingchannel 152 of FIG. 15, the axially extending channel 174 has a widthless than the outside diameter of the association loop filament. Thecombination of the enlarged opening 173 of the channel 172 and thereduced width of the channel 174 facilitates hooking the associationloop 1 into the L-slot 170 and, at the same time, impedes, and in someconfiguration prohibits, the association loop 1 from becoming unhooked.

FIG. 18 depicts another alternative embodiment slot structure 180 in adistal end 186 of a delivery device shaft 188. In contrast to previousL-shaped slots, the slot structure 180 of FIG. 18 is T-shaped, includinga radially extending channel 182 and an axially extending channel 184.As in the case of the previously discussed L-shaped slots, the axiallyextending channel 184 includes a distally extending channel portion 184a. However, in addition, in the slot structure 180, the axiallyextending channel 184 also includes a proximally extending channelportion 184 b. One advantage of the T-shaped structure 180 is that ittends to cause the association loop 1 to remain within channel 184regardless of whether the shaft 188 is moved in the proximal directionor the distal direction. More specifically, in response to the deliverydevice shaft 188 being inserted into a patient's body and moved in adistal direction, the association loop 1 tends to slide into the channelportion 184 b. Alternatively, in response to moving the shaft in theproximal direction, the association loop tends to slide into the channelportion 184 a. In either case, the association loop 1 tends to stayhooked within the structure 180. It should be noted that any of thepreviously described modifications to the dimensions of the L-shapedslot may also be applied to the T-shaped slot of FIG. 18.

The association loop 1 is may be unhooked from the T-shaped slot 180 bypositioning the association loop 1 at the inner terminal end of theradially extending channel 182 and sliding the association loop 1radially out of the slot 180.

As now described, the invention also may include a structure thatoverhangs the entrance to the L- or T-shaped slot to further reduce thelikelihood of the association loop inadvertently coming unhooked fromthe delivery device shaft. Preferably, such structures are deformable tothe degree that they do not prohibit the association loop from comingunhooked, but instead impedes its exit from the L- or T-shaped slot.However, in alternative configurations, such structures may besufficiently rigid to prohibit the association loop from comingunhooked. In various illustrative embodiments, the overhanging structuretakes the form of a sheath or tube having a portion placed over aportion of the radially extending channel opening. The structuresdiscussed below can be employed, for example, with any of the slotstructures discussed above. In one illustrative embodiment, the belowdiscussed structures are formed as a coating on the delivery deviceshaft. In other illustrative embodiments, they may be formed from aheat-shrink tubing cut to a suitable shape and interfitted over thedelivery device shaft. The overhanging structures may be formed from avariety of flexible and/or resilient materials, such as a polymerplastic. Preferably, they are fixedly attached to the delivery deviceshaft, and may in some embodiments, be colored to increase visibilityand/or can be made lubricious to aid the delivery device shaft intraversing tissue in the body.

FIG. 19 is a longitudinal cross-sectional view of a delivery deviceshaft 194 having an L-shaped slot 192 of the type described above formedin a distal portion 195. A sheath 196 interfits over a portion of thedelivery device shaft 194 and extends partially over the opening to theradially extending channel 192 a. In this illustrative embodiment, thesheath is flexible enough to deflect sufficiently to allow theassociation loop 1 to enter the channel 192 a, but rigid enough toimpede, and in some configurations prohibit, the association loop 1 fromsliding out of the channel 192 a once inserted. The sheath structure ofFIG. 19 may be employed with any of the above described slot structures.

FIG. 20 depicts a cross-sectional view of another L-shaped slotstructure 212 formed in a distal end 215 of a delivery device shaft 214.As depicted, the L-shaped slot 212 includes both a radially extendingchannel 212 a and an axially extending channel 212 b. The illustrativeembodiment of FIG. 20 also includes a sheath 216 interfitted over theshaft 214 and located on the proximal side of the channel 212 a. Theillustrative sheath 216 includes a flap 216 a, which extends axially ina distal direction to at least partially overlap with the opening to theradially extending channel 212 a. The extension flap 216 a is flexibleenough to deflect inward toward the axially extending channel 212 b toenable a medical operator to insert the association loop 1 into theradially extending channel 212 a. However, the extension flap 216 a isalso rigid enough to impede, and in some configurations prohibit, theassociation loop 1 from sliding out of the first channel 212 asubsequent to insertion. As in the case of the structure 196 of FIG. 19,the structure 216 a may be sized and shaped to be employed with anysuitable slot structure, including any of those described herein.Additionally, the extension flap 216 a need not be supported with thesleeve 216, but instead may be supported in place with any suitablestructure.

FIG. 21 depicts another illustrative L-shaped slot structure 232 formedin a distal end 234 of a delivery device shaft 236. The illustrativeembodiment of FIG. 21 also includes a sheath 238 interfitted over thedelivery device shaft 236. The sheath 238 includes a slotted portion 240that aligns with the radially extending channel 232 a. As shown, theslotted portion 240 is defined by the sheath walls 240 a and 240 b, andis narrower than the radially extending channel 232 a, and preferablynarrower than the diameter of the filament forming the association loop1. According to the illustrative embodiment, the sheath walls 240 a and240 b are sufficiently resilient to deflect outward to enable expansionof the slot 240 and insertion of the association loop 1. Subsequent toassociation loop 1 insertion, the sheath walls 240 a and 240 b expandback to a normal position to impede, and in some configurationsprohibit, the association loop 1 from sliding back out the radiallyextending channel 232 a. As depicted, the sheath 238 also includes anaxially extending slotted portion 239 for enabling the association loop1 to slide distally into the axially extending channel 232 b. Althoughthe axially extending slotted portion 239 is depicted as having the samewidth as the channel 232 b, this need not be the case. The axiallyextending slotted portion 239 of the sheath 238 may have a larger widthor, in some configurations, a smaller width to further impede theassociation loop 1 from unhooking from the slot 232.

It is to be understood that a sheath interfitted over a delivery deviceshaft as described above may have other configurations. For example, ahood portion 240 c of the sheath 238, including sheath wall 240 a, neednot be present. Instead, the sheath wall 240 b may act alone to impede,and in some configurations prohibit, the association loop 1 from slidingback out the radially extending channel 232 a.

FIG. 22 depicts another illustrative slot and sheath combination 242.The illustrative embodiment 242 is substantially the same as theillustrative embodiment of FIG. 21, except that the sheath 246 includesa curved slotted section 248. The curved slotted section 248 preferablyaligns with the radially extending channel 244 a. The curved nature ofthe slotted section 248 acts both to ease the insertion of theassociation loop 1 into the L-shaped slot 244 and to reduce thelikelihood of the association loop 1 sliding back out of the radiallyextending channel 244 a. The sheath portions 248 a and 248 b that formthe curved slotted section 248 accomplish this by cooperating toconstrain the association loop 1, when inserted into the slot 244, fromre-entering the radially extending channel 244 a. More specifically, inthis embodiment, the sheath portion 248 b extends across the innerterminal end of the channel 244 a into the channel 244 b. The sheathportion 248 b thus acts as a flap. For example, when the associationloop 1 is slid into the channel 244 a, the sheath portion 248 b deflectsdownward to allow the association loop 1 to slide into the channel 244b. The sheath portion 248 b then prevents the association loop 1 fromexiting the channel 244 b because, as the association loop 1 is pulledinto the channel 244 a, the sheath portion 248 b deflects against thewall of the channel 244 b to block the entrance to the channel 244 a.

Any of the above described association loop and dilator assemblies ofFIGS. 1-9 and L- or T-shaped slots of FIGS. 13-22 may be used incombination and coordinated to ease insertion of an association loopinto a slot, restrict or allow freedom of movement of the associationloop within the slot, and impede the association loop from becomingunhooked from the slot. The dimensions of an association loop and a slotmay be coordinated to facilitate the above. FIGS. 23A and 23B illustratethe interaction between an association loop on an end of a slingassembly and a slot near a distal end of a delivery device.Specifically, FIGS. 23A and 23B use the loop and dilator structure ofFIG. 10 and a shaft 134 of the delivery device of FIG. 13 fordemonstrating the coordination of the dimensions of an association loopand a slot on a delivery device.

FIG. 23A depicts the loop and dilator structure of the implant assemblyof FIG. 10 and a slot 132 near the distal end 130 of the shaft 134 ofFIG. 13 before the mating structures, e.g., the association loop 104 andthe slot 132, are associated. The association loop 104 may be sized suchthat it has a diameter larger than or equal to the diameter I of theshaft 134 such that the association loop 104 may be slid over the distalend 130 of the delivery device shaft 134. The association loop 104, andthus, one end of a sling assembly, is hooked onto the shaft 134 byradially sliding the association loop 104 into channel 133 and axiallysliding the association loop 104 to a distal end 135 a of the channel135.

FIG. 23B depicts the association loop 104 hooked onto the second channel135 of the L-shaped slot 132. The loop 104, when positioned at thedistal end 135 a of the second channel 135, is constrained in the slot132. As depicted, the loop 104 has a length sufficiently large to slideover the delivery device 134 and sufficiently short that a portion 134 cof the delivery device 134 (from the distal end 135 a of the axialchannel 135 to the distal tip 130 of the shaft 134) prevents the dilator112 from crossing the axis 136 around the distal tip 130 of the shaft134. Even when the dilator 112 is pulled to extend the association loop104 as far as possible, the length H of the portion 134 c of the shaft134 is longer that the association loop 104 and keeps the dilator 112 ona side 134 a of the shaft 134. The diameter I and the length H of theportion 134 c of the shaft 134 and the length of the association loop104 all may vary yet still be selected relative to each other tomaintain the dilator 112 on one side, e.g., side 134 a of the shaft 134.This feature allows the loop 104 to be removed in specific directions.For example, to remove the loop 104 from the shaft 134, the loop 104 isslid towards the proximal most position in the second channel 135, isrotated 180 degrees around the axis 136 of the shaft 134 to remove theassociation loop 104 from the L-shaped slot 132, and slid back off thedistal tip 130 of the shaft 134. When the association loop 104 isrotated 180 degrees around the delivery device shaft 134, theassociation loop 104 encircles the shaft 134 and the distal tip of thedilator 112 points towards the opening of the L-shaped slot 132.

In an alternative embodiment, the diameter I and the length H of theportion 134 c of the shaft 134 and the length of the association loop104 may be varied so that the dilator 112 may crossing the axis 136around the distal tip 130 of the delivery device shaft 134 to a side 134b. For example, the length of the association loop 104 may be selectedto be long enough to that portion 134 c does not prevent the dilator 112from crossing the axis 136 around the distal tip 130. In anotherembodiment, the length of the association loop 104 may be selected to belong enough to that portion 134 c prevents the dilator 112 from crossingthe axis 136 around the distal tip 130 of the shaft 134 when theassociation loop 104 is not fully extended. However, when the dilator112 is pulled to extend the association loop 104, the association loop104 becomes longer than the length H of the portion 134 c of the shaft134 and allows the dilator 112 to cross the axis 136 around the distaltip 130 of the delivery device shaft 134 from side 134 a to side 134 b.

FIG. 24 shows another embodiment of a structure, a ball anchor-dilatorassembly 280, that can be attached to an end of a sling assembly. Inthis embodiment, a wire 282 extends from a dilator 284 and terminates ina ball anchor 286. The ball anchor 286 can be attached to the end of thewire 282 or it can be molded to the end of a wire 282. The ball anchor286 can be rigid or elastic. Although the anchor is depicted in theshape of a ball, it is understood that the anchor may be any regular orirregular shape, such as crescent, square, rectangular, bar, star, etc.

FIG. 25 depicts the ball-dilator assembly 280 and a complementarystructure near the distal end of the shaft 290. As depicted, the shaft290 can be constructed such that it has a ball receiving slot 291located near the distal tip of the delivery device 290. The ball anchormay be snapped or otherwise inserted into the proximal end 291 a of theslot 291. In one embodiment, where an elastic ball is used as the ballanchor 286, the proximal end 291 a of the slot 291 for receiving theball anchor 286 has a size smaller than the size of the ball anchor 286.In this embodiment, the ball anchor 286 is compressed as it is insertedinto the proximal end 291 a of the slot 291 and expands in theball-shaped proximal end 291 a of the slot 291 when inserted to preventthe ball anchor 286 from inadvertently separating from the proximal end291 a of the slot 291.

In an alternative embodiment where the ball anchor 286 is rigid, theproximal end 291 a of the slot 291 in the delivery device 290 may bemade to the size of the ball anchor 286 and the ball anchor 286 is madeto snap into the proximal end 291 a of the slot 291 of the deliverydevice 290.

It is to be understood that any of the slots described herein, such asslot/sheath combinations, slots of varying dimensions, and slotsincluding indentations and/or protuberances may be employed incombination with any of the associations loops described herein.Furthermore, the above described illustrative structures may be employedwith any of the described delivery devices, or others known in the art,including the suprapubic, transobtural, and transvaginal deliverydevices described below.

FIG. 26 depicts a delivery device 270 for delivering a sling assembly,such as the sling assembly 10 depicted in FIG. 1, to an anatomicallocation in the body of a patient. The delivery device 270 includes ahandle 271 and, extending from the handle 271, a needle shaft 272 whichis composed of a first straight section 272 a, a curved section 272 b,and a second straight section 272 c. The first straight section 272 a ofthe shaft 272 is permanently affixed to and extends distally from adistal end of the handle 271. The curved section 272 b of the shaft 272extends distally from the first straight section 272 a. The secondstraight section 272 c extends distally from the curved section 272 b,and terminates at a distal end to form a conical tip 272 d. The shaft272 of the delivery device 270 is formed of surgical grade stainlesssteel and, excluding the conical tip 272 d, has a constant diameteralong its length. An L-shaped slot 279, which may be any of the slotstructures described herein, is positioned on the second straightsection 272 c near the distal end of the delivery device 270.

In use, the shaft 272 is employed to create a passage through bodytissue, namely, from the abdomen to the vagina. An incision is made oneach side of the midline of the body in the lower abdomen and anincision is made in the vaginal wall. The shaft 272 of the deliverydevice 270 is inserted through one abdominal incision down along theposterior surface of the pubic bone through the vaginal incision. Anassociation loop, which may be any of the association loops describedherein, slides into the L-shaped slot 279 to hook one end of a slingassembly onto the distal end of the shaft 272. This process may berepeated with a second association loop and the delivery device 270 or asecond delivery device similar to or the same as delivery device 270 onthe contralateral side of the body. With both delivery devices placed,cystoscopy may be performed to ensure bladder integrity. The twodelivery devices 270 may be withdrawn from the abdominal incisions,drawing each end of the sling assembly through the respective passagescreated by the shafts of the delivery devices. The association loops arethen unhooked from the respective delivery devices. The dilators may beused as handles to adjust the position of the sling assembly to achievedesired placement. Once desired placement of the sling assembly isachieved, the tabbed spacer, and thus the looped portion of the bottomside of the plastic sleeve, is cut. Then, by pulling upward on thedilators, the medical operator slides the plastic sleeve off the knittedmesh and removes it from the body. The delivery devices and the plasticsleeve, including the dilators, are then discarded.

In another aspect, the invention includes coloring the shaft of thedelivery device so that that the needle shaft of the delivery device isvisible. The shaft can be colored by either attaching a colored tubingor sheath, or by chemically coloring the shaft of the delivery device. Aheat-shrink tubing 277 may be thermobonded to the needle shaft 272. Asdepicted, the heat-shrink tubing 277 can extend the length of the needleshaft 272 to act as a visible coating to aid the physician duringcystoscopy. The colored heat-shrink tubing 277 can be configured toterminate at a location on the needle shaft 272 of the delivery device270 that corresponds to the opening of the slot 279 and can thus serveto prevent the association loop from disengaging freely from the needleshaft 272. Alternatively, the heat-shrink tubing 277 can extend justpartially along the length of the needle shaft 272. The colored needleshaft aids the user during cystoscopy. In another embodiment, anelectrochemical process can be used to provide a colored finish on theneedle shaft 272 of the delivery device 270 to facilitate needlevisibility during cystoscopy. Any color can be used such as green, blue,yellow or orange. In one example, the finish includes a blue chromeoxide finish.

In an alternative embodiment, although not shown, the delivery device270 of FIG. 26 may be configured for a transvaginal or a prepubicprocedure. For example, the slot 279 may be oriented such that theaxially extending channel of the slot 279 extends proximally towards thehandle 271, instead of distally toward the distal end of the shaft 272.When configured for a transvaginal or a prepubic procedure, the deliverydevice may be shaped and sized the same as or differently from thedelivery device 270 of FIG. 26. For example, the shaft 272 may beconfigured shorter than for a suprapubic procedure or incorporate adifferent curve radius. A transvaginal or a prepubic procedure issimilar to suprapubic procedure described above, however, a slingassembly is hooked onto a delivery device via an association loop andthen is inserted from a vaginal incision to an abdominal incision overor under the pubic bone.

FIG. 27 shows another illustrative delivery device 300 particularlysized and shaped for transobtural placement of an implantable sling, andemployable with any of the illustrative embodiments of FIGS. 1-25. FIG.30 depicts a side view of a delivery device 300 according to anillustrative embodiment of the invention. The delivery device 300includes a handle 312, a shaft 314, and a transitional portion 317extending distally between a distal end 312 a of the handle 312 and aproximal end of the shaft 314. The transitional portion 317 includes afirst straight section 317 a, a curved section 317 b and a secondstraight section 317 c, all lying substantially in a single plane, andmay be formed as either part of the shaft 314 or as part of the handle312. The shaft 314 includes a curved section 314 a, a straight section314 b and a conical tip 314 c, all lying substantially in the same planeas the transitional portion 317. In the illustrative embodiment, thefirst straight section 317 a of the transitional portion 317 attaches tothe distal end 312 a of the handle 312, extends distally along a firstaxis 311, and preferably has a substantially constant diameter. Thecurved section 317 b of the transitional portion 317 extends from adistal end of the first straight section 317 a, curves away from thefirst axis 311, and also preferably has a substantially constantdiameter. The second straight section 317 c extends from a distal end ofthe curved section 317 b along a second axis 313, and preferably has adiameter that decreases from its proximal end to its distal end toprovide increased structural stability to the shaft 314. The curvedsection 314 a, preferably, has a substantially constant diameter,smaller than the diameter of the curved section 317 b of thetransitional portion 317, and extends from the distal end of the secondstraight section 317 c of the transitional portion 317, curves backtoward the first axis 311, and terminates at a distal end approximatelyat an intersection with the first axis 311. The straight section 314 b,preferably, has a substantially constant diameter and extends from thedistal end of the curved section 314 a along a third axis 315, whichcrosses the first axis 311. In one configuration, a conical tip 314 cextends distally from the straight section 314 b. In anotherconfiguration, the distal portion 319 of the delivery device 300 mayinclude a structure or feature 320 for associating the delivery device300 with a sling and/or sling assembly or an end of a sling and/or slingassembly, such as any of the slot structures described herein. Thedelivery device of FIG. 30 may be employed with any of the abovedescribed loop and dilator assemblies described herein.

In use, the shaft 314 is employed to create a passage through bodytissue, namely, from just lateral to the inferior pubic ramus throughthe obturator foramen to the vagina. Three incisions are made to thebody of the patient. A first incision is made just lateral to theinferior pubic ramus at the junction where the inferior pubic ramus andthe adductor longus muscle meet. A second incision, corresponding to thefirst incision, is made on the contralateral side. A third incision ismade in the anterior vaginal wall and dissected bilaterally to theinterior portion of the inferior pubic ramus. The handle 312 is graspedin one hand, and the shaft 314 of the delivery device 300 is insertedthrough one ischiopubic incision in a downward motion, piercing theobturator muscle and obturator membrane. Then the handle 312 is turnedto a position 45 degrees to the midline of the patient's body. Aforefinger of the opposite hand is placed in the lateral dissection ofthe vaginal incision and on the distal end of the delivery device 300.The forefinger is used to guide the distal end of the shaft 314 aroundthe inferior pubic ramus through the vaginal incision.

Next, a first association loop is slid over the distal end of the shaft314 and into a slot 320 to hook one end of a sling assembly onto thedelivery device 300. The delivery device 300 is then withdrawn from theischiopubic incision, drawing one end of the sling assembly through thepassage created by the shaft 314 of the delivery device 300. Theassociation loop is then unhooked from the delivery device 300. Thisprocess is repeated with a second association loop and the deliverydevice 300, or a second delivery device the same as or similar to thedelivery device 300, on the contralateral side of the body. A singlecystoscopy may be performed at this time to ensure bladder integrity.Then the dilators may be used as handles to adjust the position of thesling assembly to achieve desired placement. Once desired placement ofthe sling assembly is achieved, the tabbed spacer, and thus the loopedportion of the bottom side of the plastic sleeve, is cut. Then, bypulling upward on the dilators, the medical operator slides the plasticsleeve off the knitted mesh and removes it from the body. The deliverydevices and the plastic sleeve, including the dilators, are thendiscarded.

FIGS. 28A, 28B and 28C show another illustrative delivery device 340also particularly sized and shaped for transobtural placement of animplantable sling, and employable with any of the above described loopand dilator assemblies described herein, including those of FIGS. 2-9.The delivery device 340 includes a handle 342 with a first substantiallystraight section 342 a, a curved section 342 b, and a secondsubstantially straight section 342 c located substantially in a firstplane, a transitional portion 345 extending out of a distal end 343 ofthe handle 342, and a shaft 344 extending from a distal end of thetransitional portion 345. The shaft includes curved section 344 a, astraight section 344 b, and in one configuration, terminates in aconical tip 344 c. The distal portion 349 of the delivery device 340 mayinclude a structure or feature 348, for example, a slot structure asdepicted in FIGS. 13-25, for associating the delivery device 340 with asling and/or sling assembly or an end of a sling and/or sling assembly.The delivery device of FIGS. 28A, 28B and 28C may be employed with anyof the above described loop and dilator assemblies described herein,including those of FIGS. 2-9.

The transitional portion 345 interfits and extends axially out of thedistal end 343 of the second handle section 342 c to affix the shaft 344to the handle 342. As a result, the transitional portion 345 issubstantially co-planar with the handle 342 in the first plane. Thecurved section 344 a of the shaft 344 extends from a distal end of thetransitional portion 345. The straight section 344 b of the shaft 344extends from a distal end of the curved section 344 a. The curvedsection 344 a and the straight section 344 b are substantially coplanarin a second plane. According to the illustrative embodiment of FIGS.28A, 28B and 28C, the first and second planes are substantiallyorthogonal to each other. However, the first and second planes may be atany suitable angle (e.g., about 10, 20, 30, 45, 60, 70 or 80 degrees) toeach other.

To provide structural reinforcement, sections 342 b and 342 c have crosssectional diameters that taper to be smaller at the distal end 343 ofthe handle 342. Additionally, rather than having the tapered section 317c of the transitional portion 317 being formed as part of the shaft 314,as shown in FIG. 27, the tapered portions 342 b and 342 c of theembodiment of FIGS. 28A, 28B and 28C are formed as part of the handle342. According to one feature, this configuration reduces the length ofthe transitional portion 345 and thus, provides improved structuralsupport for the curved section 344 a. Preferably, in operation, neitherthe handle 342 nor the intermediate/transitional portion 345 extendsinto the body of the patient, and provides a positive stop against thisoccurring.

In use, the shaft 344 is employed to create a passage through bodytissue, namely, from just lateral to the inferior pubic ramus throughthe obturator foramen to the vagina. Three incisions are made to thebody of the patient. A first incision is made just lateral to theinferior pubic ramus at the junction where the inferior pubic ramus andthe adductor longus muscle meet. A second incision, corresponding to thefirst incision, is made on the contralateral side. A third incision ismade and dissected bilaterally in the anterior vaginal wall. The handle342 of the delivery device 340 is grasped in one hand, and the shaft 344is inserted into the ischiopubic incision perpendicular to the skin withthe first section 342 a of the handle 342 at a 45-degree angle parallelwith the thigh. A forefinger of the opposite hand is placed in thelateral dissection of the vaginal incision. The thumb of the oppositehand is placed on the outside of the curve of the shaft 344, and adownward force is applied, allowing the shaft 344 to pierce through theobturator foramen. The shaft 344 is then rotated medially around theinferior pubic ramus to meet the forefinger of the opposite hand, whichguides the conical tip 349 of the shaft 344 through the vaginalincision. It is our understanding that during this procedure, thetransition portion 345 does not extend into the ischiopubic incision.

Next, a first association loop is slid over the distal end of the shaft344 and into a slot 348 to hook one end of a sling assembly onto thedelivery device 340. The delivery device 340 is then withdrawn from theischiopubic incision, drawing one end of the sling assembly through thepassage created by the shaft 344 of the delivery device 340. Theassociation loop is then unhooked from the delivery device 340. Thisprocess is repeated with a second association loop and the deliverydevice 340, or a second delivery device the same as or similar to thedelivery device 340, on the contralateral side of the body. A singlecystoscopy may be performed at this time to ensure bladder integrity.Then the dilators may be used as handles to adjust the position of thesling assembly to achieve desired placement. Once desired placement ofthe sling assembly is achieved, the tabbed spacer, and thus the loopedportion of the bottom side of the plastic sleeve, is cut. Then, bypulling upward on the dilators, the medical operator slides the plasticsleeve off the knitted mesh and removes it from the body. The deliverydevices and the plastic sleeve, including the dilators, are thendiscarded.

Preferably, the delivery devices and/or delivery assemblies of theinvention are made of biocompatible materials, which can include, forexample, polyethylene/ethylene vinyl acetate (EVA) blend, polyethylene,polyester, nylon, polypropylene, thermoplastic fluorinated ethylenepropylene (FEP), TFP, stainless steel, malleable metal or anycombination of these materials. Preferably, a shaft of a delivery deviceof the invention is formed of surgical grade stainless steel.

The drawings are not necessarily to scale; emphasis instead is generallyplaced upon illustrating the principles of the invention.

Variations, modifications, and other implementations of what isdescribed herein will occur to those of ordinary skill without departingfrom the spirit and the scope of the invention. Accordingly, theinvention is not to be limited only to the preceding illustrativedescription. For additional illustrative features that may be used withthe invention, including the embodiments described here, refer to thedocuments listed herein above and incorporated by reference in theirentirety. All operative combinations between the above describedillustrative embodiments and those features described in U.S. patentapplication Ser. No. 10/642,365, entitled “Systems, methods and devicesrelating to delivery of medical implants,” are considered to bepotentially patentable embodiments of the invention.

1. A sling assembly comprising, a sleeve having a first end and a secondend, a sling residing, at least partially, within the sleeve, and anassociation loop located at a first end of the sling assembly and sizedand shaped for associating the sling assembly with a shaft of a deliverydevice.
 2. The assembly of claim 1, comprising a dilator having a firstend and a second end, and attached to a first end of the sleeve.
 3. Theassembly of claim 1, wherein the association loop associates the sleevewith a delivery device.
 4. The assembly of claim 1, wherein the loop isformed from a single strand of material.
 5. The assembly of claim 1,wherein the loop is formed from multiple strands of material.
 6. Theassembly of claim 5, wherein the multiple strands are braided.
 7. Theassembly of claim 6, wherein the multiple strands form a hollow tube. 8.The assembly of claim 1, wherein the loop is coated with a shaperetaining material.
 9. The assembly of claim 3, wherein the plurality ofstrands is twisted.
 10. The assembly of claim 1, wherein the loop isformed from metal.
 11. The assembly of claim 1, wherein the loop isformed from polymer.
 12. The assembly of claim 2, wherein the loop hastwo ends embedded along the length of the dilator.
 13. The assembly ofclaim 2, wherein a material forming the loop axially extends into thesecond end of the dilator.
 14. The assembly of claim 13, comprising aspring loaded mounting arrangement to enable the loop to extend andretract axially relative to the dilator.
 15. The assembly of claim 13,comprising a fixed mounting arrangement between the dilator and the loopmaterial within the dilator.
 16. A delivery device comprising a shafthaving a proximal end and a distal end, and a slot located near thedistal end, the slot including a radial portion extending radially intothe shaft to an inner terminal end, and an axial portion extendingaxially along the shaft from the inner terminal end of the radialportion.
 17. The delivery device of claim 16, comprising a conical tipon the distal end of the shaft.
 18. The delivery device of claim 17,wherein shaft has a constant diameter.
 19. The delivery device of claim17, wherein shaft has a diameter of about 3 mm.
 20. The delivery deviceof claim 16, wherein the radial portion extends about 2 mm into theshaft.